FDA.reportPublic FDA data

De Novo DEN140010

Device
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
Contact
kay a taylor
De Novo number
DEN140010
Product code
PJI
Regulation
866.5930
Classification name
severe combined immunodeficiency disorder (scid) newborn screening test system
Decision
granted (DENG)
Decision date
2014-12-15
Date received
2014-02-19
Classification advisory
Immunology
Review advisory
Pathology
Type
Direct

Current FDA Classification#

Product code
PJI
Device name
Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Medical specialty
Immunology
Device class
2
Regulation
866.5930
Implant
N
Life sustain/support
N